Patient-reported long-term benefit with an active transcutaneous bone-conduction device.

PURPOSE: To evaluate the long-term benefits in hearing-related quality of life, patient satisfaction and wearing time of patients rehabilitated with an active transcutaneous bone-conduction device. Adverse events and audiological outcomes are reported as secondary outcomes. METHODS: This retrospective, mono-centric cohort analysis involves 16 adults with conductive or mixed hearing loss with a mean device experience of 51.25 months. Patient-reported outcome measures were assessed using the short version of the Speech, Spatial and Qualities of Hearing Scale (SSQ12-B) and the German version of the Audio Processor Satisfaction Questionnaire (APSQ). Audiological outcomes as well as incidence of adverse events were obtained from patients´ charts. RESULTS: The hearing-related quality of life improved significantly within all subscales of the SSQ12-B scoring a mean overall of 2.95 points. Patient satisfaction measured with the APSQ scored 8.8 points on average. Wearing times differed considerably and patients with lower levels of education seemed to use their device longer compared to patients with academic education. Eight minor adverse events were documented, all of which resolved during follow-up. The mean gain in word recognition score at the last follow-up measured at 65 dB was 75.9%, while speech reception threshold was lowered by 35.1 dB. CONCLUSION: Even after several years, patients report significant benefits in hearing-related quality of life and device satisfaction. In combination with a low rate of minor adverse events and significantly improved audiological outcomes, the device is considered as a comfortable and effective option in hearing rehabilitation.

A rare case presentation of Tuberculous Otitis Media with turner syndrome.

A 17-year-old female patient who came to the Otorhinolaryngology and Head and Neck Surgery department with chief complaints of bilateral ear discharge and hearing loss Since 1 year. She was diagnosed as a case of Turner syndrome based on Cardic-CT, USG-pelvis, CT-MRI Pelvis with Abdomen Screening, and Chromosomal analysis revealed 45, X pattern in all the metaphases. In the Preoperative investigations, Pure tone audiometry shows left ear (83dB HL) severe mixed hearing loss and right ear has (63dB HL) with moderately severe mixed hearing loss and in HRCT-Temporal bone features suggesting the most possibility of bilateral Cholesteatoma. Pre operatively Left ear soft tissue Histopathological examination was showed Cholesteatoma with active inflammation. Tympanomastoidectomy was planned for left ear and performed the procedure was Canal wall down mastoidectomy with type 3 tympanoplasty. Intraoperatively findings were thick KORNER'S septum, full of pale non bleeding granulations in antrum, aditus and around ossicles were observed in the middle ear. After surgery, Postoperative histopathology report showed necrotizing granulomatous inflammation consistent with tuberculosis (special stain for AFB is positive). In conclusion primarily this is a very rare case of Tuberculous Otitis Media. In such type of cases there are more chances of misdiagnosing by many clinicians as Tuberculosis was rarely occur in the ear and most of the findings are also absent as seen in our case. It is difficult to identify and diagnose the case at initial stages of a disease. In such type of cases outcome of patients is poor due to delayed diagnosis.

Long-term Outcomes of Clip Coupler Implantation in Patients with Unilateral Congenital Aural Atresia.

OBJECTIVE: To evaluate the long-term safety and efficacy of the Clip coupler attached to the stapes head in patients with unilateral congenital aural atresia (CAA). METHODS: This single-center retrospective study included 16 Mandarin-speaking patients who had unilateral microtia accompanied by CAA. All patients were divided into two groups: the short-term follow-up group (n = 9) and the long-term follow-up group (n = 7). The floating mass transducer of the Vibrant Soundbridge (VSB) was positioned in the stapes head by the Clip coupler. The safety of the VSB was investigated by comparing preoperative and postoperative bone-conduction (BC) thresholds as well as by complications. The effectiveness was evaluated by functional gain (FG), word recognition score (WRS), speech reception threshold (SRT) and signal-to-noise ratio (SNR). RESULTS: Pre- and post-operative BC thresholds were no different in all patients. And no complications developed. VSB-aided thresholds in the free-field had improved significantly in both short- and long-term follow-up groups. The improvements of WRS were observed in two groups. The monosyllabic VSB-aided WRS in the long-term follow-up group was significantly higher than that in the short-term follow-up group. When speech was from the impaired ear and noise presented to the side of normal ear (SVSBNCL), lower SNRs were found in two groups after VSB implantation. However, there was no statistical difference in aided SNR between the two groups at SVSBNCL status. CONCLUSIONS: Our results show that the FMT connected to the stapes head is a secure and useful device for patients with unilateral CHL/MHL, not only in terms of improved hearing thresholds, but also improved speech intelligibility in quiet and noisy environments.

Ten years of experience with the Ponto bone-anchored hearing system-A systematic literature review.

BACKGROUND: Bone-anchored hearing systems (BAHSs) are widely used for hearing rehabilitation and are indicated in cases of conductive and mixed hearing loss and in single-sided deafness. The Ponto system, that is one available option, has been on the market since 2009. OBJECTIVE OF REVIEW: The aim of this study is to systematically review the literature reporting on the Ponto system, with regard to audiological and surgical outcomes and patient's quality-of-life scores. TYPE OF REVIEW: A systematic literature search was performed in the PubMed database 2009-July 2019. SEARCH STRATEGY: Search term: ((osseointegrated hearing aid) OR (bone conduction implant) OR (bone anchored hearing) OR BAHA OR BAHS OR BAHI). Pre-defined inclusion and exclusion criteria were applied. EVALUATION METHOD: English-language articles reporting original clinical data (audiological, surgical or quality-of-life outcomes) on the Ponto system were included. Articles reporting on Ponto and another BAHS system where the results on Ponto constituted less than 50% of the patient population or including only results on testband or softband devices were excluded. RESULTS: Audiological outcomes were discussed in 20 publications. Improvement against the unaided thresholds was demonstrated. The functional improvement was on average 33.9 dB. The effective gain or remaining air-bone gap was on average 6.7 dB. All evaluated data showed aided speech reception thresholds significantly below normal speech level. Twenty-seven publications reported surgical and follow-up data for the Ponto system. Implant survival was 97.7%, adverse skin reactions (Holgers ≥ 2) were 5% across visits and 15% across patients. No complications were life-threatening, causing permanent disability/damage or requiring a hospitalisation. Five studies reported quality of life using the Glasgow benefit inventory, 98% reported an improvement when analysing the score on an individual level. CONCLUSIONS: The outcomes of this systematic review confirm that percutaneous systems provide consistent audiological benefits and improved quality of life for patients. Further, the review demonstrates that the percutaneous systems are safe, with relatively low complication rates. Skin-related complications are the most common complication type and are experienced by approximately one patient out of seven, or in less than one of 20 follow-up visits.

Three-Year Follow-Up with the Bone Conduction Implant.

BACKGROUND: The bone conduction implant (BCI) is an active transcutaneous bone conduction device where the transducer has direct contact to the bone, and the skin is intact. Sixteen patients have been implanted with the BCI with a planned follow-up of 5 years. This study reports on hearing, quality of life, and objective measures up to 36 months of follow-up in 10 patients. METHOD: Repeated measures were performed at fitting and after 1, 3, 6, 12, and 36 months including sound field warble tone thresholds, speech recognition thresholds in quiet, speech recognition score in noise, and speech-to-noise thresholds for 50% correct words with adaptive noise. Three quality of life questionnaires were used to capture the benefit from the intervention, appreciation from different listening situations, and the ability to interact with other people when using the BCI. The results were compared to the unaided situation and a Ponto Pro Power on a soft band. The implant functionality was measured by nasal sound pressure, and the retention force from the audio processor against the skin was measured using a specially designed audio processor and a force gauge. RESULTS: Audiometry and quality of life questionnaires using the BCI or the Ponto Pro Power on a soft band were significantly improved compared to the unaided situation and the results were statistically supported. There was generally no significant difference between the two devices. The nasal sound pressure remained stable over the study period and the force on the skin from the audio processor was 0.71 ± 0.22 N (mean ± 1 SD). CONCLUSION: The BCI improves the hearing ability for tones and speech perception in quiet and in noise for the indicated patients. The results are stable over a 3-year period, and the patients subjectively report a beneficial experience from using the BCI. The transducer performance and contact to the bone is unchanged over time, and the skin area under the audio processor remains without complications during the 3-year follow-up.

Effects of the Conductive Component of Hearing Loss on Speech Discrimination Ability.

OBJECTIVES: Effects of decreasing auditory activity on speech discrimination ability are not fully understood. To investigate influence of decrease in auditory activity due to conductive and sensorineural components of hearing loss (HL) on speech discrimination ability. MATERIALS AND METHODS: We retrospectively reviewed medical records of patients with suspected HL at Kitasato University Hospital in 2017 and 2018. Patients were divided according to pure-tone audiometry findings: no HL (N-HL), conductive HL (C-HL), sensorineural HL (S-HL), and mixed HL (M-HL) groups. RESULTS: In total, 149 patients (224 ears) were eligible. The maximum speech discrimination score (SDSmax) for all ears significantly negatively correlated with age (r = -0.29, p<0.0001) and bone conduction (BC) threshold (r = -0.55, p<0.0001). For patients aged <50 years in N-HL and C-HL groups, SDSmax was nearly 100%, with no significant difference. SDSmax was significantly lower for older patients (≥50 years) in the M-HL group than in the S-HL group, even though there were no significant differences in age and BC thresholds between groups. CONCLUSION: Decrease of auditory activity due to the conductive component of M-HL may worsen speech discrimination ability. Early treatment of M-HL would be desirable for the preservation of auditory function.

Audiological outcome measures with the BONEBRIDGE transcutaneous bone conduction hearing implant: impact of noise, reverberation and signal processing features.

Objective: To assess the performance of an active transcutaneous implantable-bone conduction device (TI-BCD), and to evaluate the benefit of device digital signal processing (DSP) features in challenging listening environments.Design: Participants were tested at 1- and 3-month post-activation of the TI-BCD. At each session, aided and unaided phoneme perception was assessed using the Ling-6 test. Speech reception thresholds (SRTs) and quality ratings of speech and music samples were collected in noisy and reverberant environments, with and without the DSP features. Self-assessment of the device performance was obtained using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire.Study sample: Six adults with conductive or mixed hearing loss.Results: Average SRTs were 2.9 and 12.3 dB in low and high reverberation environments, respectively, which improved to -1.7 and 8.7 dB, respectively with the DSP features. In addition, speech quality ratings improved by 23 points with the DSP features when averaged across all environmental conditions. Improvement scores on APHAB scales revealed a statistically significant aided benefit.Conclusions: Noise and reverberation significantly impacted speech recognition performance and perceived sound quality. DSP features (directional microphone processing and adaptive noise reduction) significantly enhanced subjects' performance in these challenging listening environments.

Hearing Aid Treatment for Patients with Mixed Hearing Loss. Part II: Speech Recognition in Comparison to Direct Acoustic Cochlear Stimulation.

BACKGROUND: The conventional therapy for severe mixed hearing loss is middle ear surgery combined with a power hearing aid. However, a substantial group of patients with severe mixed hearing loss cannot be treated adequately with today's state-of-the-art (SOTA) power hearing aids, as predicted by the accompanying part I of this publication, where we compared the available maximum power output (MPO) and gain from technical specifications to requirements for optimum benefit using a common fitting rule. Here, we intended to validate the theoretical assumptions from part I experimentally in a mixed hearing loss cohort fitted with SOTA power hearing aids. Additionally, we compared the results with an implantable hearing device that circumvents the impaired middle ear, directly stimulating the cochlea, as this might be a better option. OBJECTIVES: Speech recognition outcomes obtained from patients with severe mixed hearing loss supplied acutely with a SOTA hearing aid were studied to validate the outcome predictions as described in part I. Further, the results obtained with hearing aids were compared to those in direct acoustic cochlear implant (DACI) users. MATERIALS AND METHODS: Twenty patients (37 ears with mixed hearing loss) were provided and fitted with a SOTA power hearing aid. Before and after an acclimatization period of at least 4 weeks, word recognition scores (WRS) in quiet and in noise were studied, as well as the speech reception threshold in noise (SRT). The outcomes were compared retrospectively to a second group of 45 patients (47 ears) using the DACI device. Based on the severity of the mixed hearing loss and the available gain and MPO of the SOTA hearing aid, the hearing aid and DACI users were subdivided into groups with prediction of sufficient, partially insufficient, or very insufficient hearing aid performance. RESULTS: The patients with predicted adequate SOTA hearing aid performance indeed showed the best WRS in quiet and in noise when compared to patients with predicted inferior outcomes. Insufficient hearing aid performance at one or more frequencies led to a gradual decrease in hearing aid benefit, validating the criteria used here and in the accompanying paper. All DACI patients showed outcomes at the same level as the adequate hearing aid performance group, being significantly better than those of the groups with inadequate hearing aid performance. Whereas WRS in quiet and noise were sensitive to insufficient gain or output, showing significant differences between the SOTA hearing aid and DACI groups, the SRT in noise was less sensitive. CONCLUSIONS: Limitations of outcomes in mixed hearing loss individuals due to insufficient hearing aid performance can be accurately predicted by applying a commonly used fitting rule and the 35-dB dynamic range rule on the hearing aid specifications. Evidently, when outcomes in patients with mixed hearing loss using the most powerful hearing aids are insufficient, bypassing the middle ear with a powerful active middle ear implant or direct acoustic implant can be a promising alternative treatment.

The vibrating ossicular prosthesis in children and adolescents: a retrospective study.

PURPOSE: The primary objective of the retrospective study was to collect speech intelligibility data on children and adolescents implanted with the vibrating ossicular prosthesis (VORP) 503. METHODS: This was a retrospective, multicentre study on 55 children and adolescents from 6 German clinics aged between 5 and 17 years suffering from mixed or conductive hearing loss implanted with a VORP 503. Pre- and postoperative bone-conduction pure tone thresholds were measured at 0.5, 1, 2 and 4 kHz, and word recognition scores in the unaided and VORP 503-aided conditions using monosyllabic speech intelligibility tests measured at 65-dB sound pressure level (SPL) were determined. RESULTS: Mean pre- and postoperative bone-conduction thresholds remained unchanged, showing the preservation of inner ear hearing. Speech intelligibility assessed in quiet at 65-dB SPL improved on average from 24.5% (SD ± 25.4) unaided to 86.4% (SD ± 13.4) aided. The average improvement of 61.9% (SD ± 25.3) was clinically and statistically significant. A total of three complications were found in the medical records of 55 subjects. The responsible investigators judged these events as procedure related. CONCLUSION: The treatment of children suffering from conductive or mixed hearing loss with the VORP 503 implant demonstrates excellent aided benefit in terms of speech understanding and only minor complications.

Prevalence of potential candidates for electric-acoustic stimulation implant in a hearing-impaired population.

OBJECTIVE: To estimate the prevalence of potential electric-acoustic stimulation (EAS) implant candidates in a hearing-impaired population through a review of auditory examinations. METHODS: In total, 7356 patients underwent audiometric examination in our department between 2011 and 2014. The prevalence of patients meeting the audiometric criteria for EAS and standard cochlear implant (CI) was assessed. RESULTS: The percentage of EAS implant candidates meeting the pure-tone audiometric criteria was 0.71% (n=34) among the hearing-impaired individuals (n=4758) examined in our department, whereas 2.52% (n=120) met the criteria for standard CI. Among the 34 EAS implant candidates, 2 individuals (5.83%) received EAS implant surgery after approval of the EAS device in Japan. CONCLUSIONS: There was a lower prevalence of EAS implant candidates than standard CI candidates. Nevertheless, healthcare professionals should carefully examine the audiograms of patients with high frequency hearing loss with regard to meeting the indication criteria for EAS implant. This will enable patients to gain access to adequate information relating to further examinations and treatment options.

Evaluation of auditory temporal processing in patients fitted with bone-anchored hearing aids.

PURPOSE: The present study aimed to identify temporal processing abilities in users of bone-anchored hearing aid (BAHA). METHODS: Seventeen subjects with BAHA (SWB) users and 29 subjects with normal-hearing were compared using the frequency pattern test, duration pattern test, and speech-in-noise test. Besides behavioral temporal processing tests, a multi-feature mismatch negativity (MMN) test was performed in BAHA users to assess the accuracy of objective auditory discrimination at the cortical level, irrespective of the subjects' attention or behavioral task. RESULTS: The results of the multi-feature MMN test showed that BAHA users could perceive differences in frequency, duration, intensity. However, no response was elicited regarding localization of stimulus and gaps within tones. Word recognition performance in noise was significantly poorer compared with normal hearing groups. All age groups showed no differences in terms of temporal processing abilities except 30-39 years duration pattern ability weaker in SWB group. CONCLUSION: The present study was the first to indicate that the use of unilateral BAHA has no effect on the localization of auditory stimuli at the cortical level according to electrophysiological test. Although Baha users have near-normal levels of hearing thresholds and temporal ordering abilities with their devices, since they benefit from the unilateral device, they still have some difficulties in resolution, recognizing and distinguishing the spatial aspects of speech, especially in multiple and noisy listening environments.

Minimal invasive pocket technique for magnet bone implant hearing aid without fixation.

INTRODUCTION: The BAHA (bone-anchored hearing aid) Attract is a magnetic transcutaneous bone conduction device anchored into the temporal bone. The standard surgical technique for BAHA Attract is a multi-tools time-consuming process, which requires a large cutaneous incision. The objective of this study is to describe and test the feasibility of a minimally invasive pocket (MIP) technique for Magnet Bone Implant Hearing Aid (MBIHA) with a modified magnet of BAHA Attract without fixation and without any tissue reduction. We use a 3-cm vertical skin incision and a subperiosteal pocket. METHOD: A study of 10 patients with conductive or mixed hearing loss who benefited from a MBIHA using the MIP technique is presented. The pure tone average (PTA) (dB) for air-conduction thresholds and the speech recognition threshold (SRT) (dB) in speech audiometry in quiet are calculated. The Entific Medical Systems (EMS) questionnaire and the postoperative clinical outcomes are realized. RESULTS: We found a significant improvement of 33.8 dB on average for the PTA and 44.8 dB for the SRT with MBIHA at 3 months, compared with unaided situation. No implant was removed or displaced after 2 years of follow-up. The skin condition remains intact in all the cases. CONCLUSION: The minimally subperiosteal pocket surgical technique MIP without fixation and with tissue preservation for the MBIHA is safe, rapid and effective for patients with conductive or mixed hearing loss. It opens new perspectives of development and modify conventional concept in magnetic coupling of bone-conducted device.

Outcomes after Application of Active Bone Conducting Implants.

BACKGROUND: A bone conducting implant is a treatment option for individuals with conductive or mixed hearing loss (CHL, MHL) who do not tolerate regular hearing aids, and for individuals with single-sided deafness (SSD). An active bone conducting implant (ABCI) was introduced in 2012 with indication in CHL, MHL, and SSD, and it is still the only ABCI available. With complete implantation of the active transducer and consequent intact skin, a decrease in infections, skin overgrowth, and implant losses, all common disadvantages with earlier passive bone conducting implants, could be expected. Our Ear, Nose and Throat Department, a secondary care center for otosurgery that covers a population of approximately 365,000 inhabitants, was approved to implant ABCIs in 2012. OBJECTIVES: Our aim was to conduct an evaluation of audiological and subjective outcomes after ABCIs. METHOD: A cohort study with retrospective and prospective data collection was performed.The first 20 consecutive patients operated with an ABCI were asked for informed consent. The main outcome measures werepure tone and speech audiometry and the Glasgow Benefit Inventory (GBI). RESULTS: Seventeen patients accepted to participate and 15 were able to complete all parts. Six patients had CHL or MHL. In this group the pure tone audiometry tests are comparable with an average functional hearing gain of 29.8 dB HL. With bilateral hearing, the mean Word Recognition Score (WRS) in noise was 35.7% unaided and 62.7% aided. Ten patients had the indication SSD. With the hearing ear blocked, the pure tone average was >101 dB HL, compared to 29.3 dB HL in sound field aided. With bilateral hearing, the mean WRS in noise was 59.7% unaided and 72.8% aided. The mean of the total GBI score was 42.1 in the group with CHL or MHL and 20.6 in the group with SSD. CONCLUSIONS: The patients benefit from their implants in terms of quality of life, and there is a substantial hearing gain from the implant for patients with conductive or MHL. Patients with SSD benefit less from the implant than other diagnoses but the positive outcomes are comparable to other options for this group.

Objective and subjective results of the Bonebridge transcutaneous active direct-drive bone conduction hearing implant.

OBJECTIVES: To investigate the effectiveness of a bone-anchored hearing implant system (Bonebridge implant technology) as a rehabilitation treatment for individuals with conductive or mixed hearing losses. Methods: This is a retrospective cohort study. Twelve implanted ears with conductive or mixed hearing losses were implanted with this device at a tertiary university hospital between 2012 and 2016. Audiological tests included pure tone air conduction (AC) and bone conduction (BC) measurements and unaided and aided sound-field thresholds. To evaluate the speech intelligibility in a quiet environment, the speech discrimination score (SDS) was tested using Arabic monosyllabic words, and the speech reception threshold (SRT) was measured using Arabic disyllabic words spoken in front of them. The subjective sound quality was assessed with the Hearing Implant Sound Quality Index (HISQUI). Results: In comparison with the unaided condition, there was a significant improvement in the aided thresholds, SDS, and SRT. Comparing the aided and unaided thresholds, the average AC threshold improved with an average functional gain of 40±6.3dB. The unaided SRT improved from 72.5 dB hearing levels (HL)(median) to 27.5 dB HL (median) when aided, and patients performed 71% better, on average, based on the SDS with the help of the device. The HISQUI questionnaire revealed high satisfaction with the device sound quality. Conclusion: Patients with conductive and mixed hearing loss substantially benefit from the Bonebridge active transcutaneous BC hearing implant.

Intraoperative Estimation of the Coupling Efficiency and Clinical Outcomes of the Vibrant Soundbridge Active Middle Ear Implant Using Auditory Brainstem Response Measurements.

Purpose This study intraoperatively measured the coupling efficiency of the Vibrant Soundbridge (VSB), with the aim of avoiding revision surgery due to insufficient outcome. This method can also be used to test the integrity of the implant at the end of the implantation surgery and to evaluate aided thresholds. In addition, this method makes it possible to objectively test how well the VSB has been fitted, provide assistance in fitting handicapped patients or children, evaluate hearing degradation, or test for a drop in coupling efficiency before revision surgeries. In order to analyze the feasibility of these new VSB-aided auditory brainstem response (ABR) thresholds, they were compared to behavioral thresholds from the Vibrogram and the preoperative bone conduction thresholds. Method The study included 30 patients with mild-to-severe hearing loss implanted with a VSB (VORP503). Intraoperative ABR thresholds during the VSB implantation were recorded using a VSB-optimized chirp stimulus. The new method is compared to the bone conduction threshold of the study sample and the aided Vibrogram thresholds. Speech intelligibility results up to 24 months after surgery are also presented. Results A reliable correlation between the bone conduction thresholds and the intraoperative ABRs was found and was higher in comparison to the Vibrogram. Furthermore, speech intelligibility outcomes were stable over time. Conclusion ABR measurements can be used intraoperatively to estimate the coupling efficiency of the VSB and test the integrity of the implant at the end of surgery.

Cochlear Nerve Hypoplasia: Audiological Characteristics in Children and Adults.

BACKGROUND: Cochlear nerve deficiency is a general term used to describe both cochlear nerve hypoplasia (CNH) and cochlear nerve aplasia. Although these two conditions can have similar results on audiological evaluation, CNH yields more variation in audiological tests. OBJECTIVES: To describe the audiological characteristics of the CNH cases in our series in relation to radiological findings. METHODS: We reviewed the medical charts, audiological findings, and radiological findings on cases with CNH. We included cases with CNH in one ear or both ears. Out of 90 subjects with CNH, we included a total of 40 individuals (21 women and 19 men; 49 ears) in the current study. We reviewed and analyzed the participants' audiological test results according to the radiological findings. RESULTS: Cases with CNH showed variations according to the cochlear structure. There were 13 normal cochleae, 4 with incomplete partition type I, and 32 with cochlear hypoplasia. The accompanying cochlear apertures also showed variation: 17 were normal, 28 stenotic, and 4 aplastic cochlear apertures. The subjects displayed hearing loss ranging from moderate to profound; furthermore, 4 subjects had no response to sound whatsoever. The degree of hearing loss was not statistically significantly different with regard to the presence or absence of cochlear malformation with CNH (p > 0.005). We observed both sensorineural hearing loss and mixed-type hearing loss among the CNH cases. CONCLUSIONS: CNH is the presence of a cochlear nerve that is smaller in diameter than the facial nerve. It can be accompanied with other associated inner ear malformations of different degrees of severity. We observed degrees of hearing loss ranging from moderate to profound.

Vibroplasty combined with tympanic membrane reconstruction in middle ear ventilation disorders.

Although the Vibrant Soundbridge is one of the most frequently used active middle ear implants, data regarding how middle ear ventilation disorders may affect the transmission behavior of its floating mass transducer are still insufficient. Studies involving coupling the floating mass transducer to the stapes head are particularly lacking. This temporal bone study evaluated the influence of simulated middle ear ventilation disorders on the middle ear transfer function in the reconstructed middle ear. The middle ear transfer function was measured using Laser Doppler Vibrometry after vibroplasty onto the stapes head, with or without tympanic membrane reconstruction. Middle ear ventilation disorders were simulated through changes in static pressure via the external ear channel with a maximum pressure of +3 kPa. Slice thickness of tympanic membrane reconstruction material was measured using micro-CT. When the reconstructed ossicular chain and the reconstructed tympanic membrane were mechanically excited by the floating mass transducer under conditions of ambient static pressure, the transmission behavior was found to be independent of the type of tissue used. Increase in static pressure up to +3 kPa caused maximum low frequency transmission loss of 15 dB when elastic grafts were used and 5 dB when stiff tissue was inserted. At high frequencies, measured loss of up to 5 dB was relatively independent of the tissue stiffness. Increase in static pressure led to displacement of the tissues towards the vestibulum and caused stiffening, especially of the annular ligament. Stiffening-induced transmission losses were mainly found at low frequencies and could not be compensated by the floating mass transducer in this range. Above 1300 Hz, the continuous force spectrum of the actuator sufficiently protected against loss of amplitude. To minimize postoperative transmission loss due to persisting ventilation disorders, choosing a very stiff tympanic membrane reconstruction material seems to be appropriate.

Benefit of Higher Maximum Force Output on Listening Effort in Bone-Anchored Hearing System Users: A Pupillometry Study.

OBJECTIVES: The aim of this study was to compare listening effort, as estimated via pupillary response, during a speech-in-noise test in bone-anchored hearing system (BAHS) users wearing three different sound processors. The three processors, Ponto Pro (PP), Ponto 3 (P3), and Ponto 3 SuperPower (P3SP), differ in terms of maximum force output (MFO) and MFO algorithm. The hypothesis was that listeners would allocate lower listening effort with the P3SP than with the PP, as a consequence of a higher MFO and, hence, fewer saturation artifacts in the signal. DESIGN: Pupil dilations were recorded in 21 BAHS users with a conductive or mixed hearing loss, during a speech-in-noise test performed at positive signal-to-noise ratios (SNRs), where the speech and noise levels were individually adjusted to lead to 95% correct intelligibility with the PP. The listeners had to listen to a sentence in noise, retain it for 3 seconds and then repeat it, while an eye-tracking camera recorded their pupil dilation. The three sound processors were tested in random order with a single-blinded experimental design. Two conditions were performed at the same SNR: Condition 1, where the speech level was designed to saturate the PP but not the P3SP, and condition 2, where the overall sound level was decreased relative to condition 1 to reduce saturation artifacts. RESULTS: The P3SP led to higher speech intelligibility than the PP in both conditions, while the performance with the P3 did not differ from the performance with the PP and the P3SP. Pupil dilations were analyzed in terms of both peak pupil dilation (PPD) and overall pupil dilation via growth curve analysis (GCA). In condition 1, a significantly lower PPD, indicating a decrease in listening effort, was obtained with the P3SP relative to the PP. The PPD obtained with the P3 did not differ from the PPD obtained with the other two sound processors. In condition 2, no difference in PPD was observed across the three processors. The GCA revealed that the overall pupil dilation was significantly lower, in both conditions, with both the P3SP and the P3 relative to the PP, and, in condition 1, also with the P3SP relative to the P3. CONCLUSIONS: The overall effort to process a moderate to loud speech signal was significantly reduced by using a sound processor with a higher MFO (P3SP and P3), as a consequence of fewer saturation artifacts. These findings suggest that sound processors with a higher MFO may help BAHS users in their everyday listening scenarios, in particular in noisy environments, by improving sound quality and, thus, decreasing the amount of cognitive resources utilized to process incoming speech sounds.

Physiology of Osseointegration.

"Bone conduction implant devices rely on osseointegration of titanium implants with the underlying skull, characterized by endosseous healing and de-novo bone formation both surrounding and onto the implant surface. The key steps in osseointegration are the initial tissue response to implantation, peri-implant osteogenesis, and peri-implant bone remodeling. There is increasing evidence that osseointegration is primarily an immune-mediated process with the key players being the complement cascade and macrophages, which form part of the host innate immunity. Implant design and composition, patient systemic factors, surgical technique, and loading characteristics can all affect the success of osseointegration."

Long-Term Outcome of Hearing Rehabilitation With An Active Middle Ear Implant.

OBJECTIVE: To assess the audiological and long-term medical and technical follow-up outcomes of an active middle ear implant. METHODS: This was a retrospective medical chart analysis of all patients provided with an active middle ear implant in a tertiary academic medical referral center between September 1, 1998, and July 31, 2015. Main outcome measures were medical and technical complications, revisions, reimplantations, explantations, coupling approaches, mean time of use, pre- and postoperative hearing thresholds, functional hearing gain across frequencies (250-4,000 Hz), and Freiburg monosyllablic word test at 65 dB. RESULTS: One hundred and three patients were identified. Fifteen were implanted bilaterally (n = 118 Vibrant Soundbridge devices [MED-EL, Innsbruck, Austria]). Seventy-seven devices were implanted for sensorineural and 41 for mixed and conductive hearing loss. Patients used the implant for 6.7 years (range 0.7 months-17.9 years) on average. Ninety-one patients (77.12%) were using the device at the end of the observation period. An overall complication rate of 16.1% was observed. The revision and explantation rates were higher for devices implanted between 2004 and 2006. The device failure rate was 3.4%. Audiological evaluation showed significant hearing gains for both hearing loss patient groups. CONCLUSION: This long-term follow-up reveals the reliability of the active middle ear implant in a single center. Overall complication rate and device failure rate are acceptable. The complication rate was higher during implementation of alternative coupling approaches. The audiological benefit was satisfactory in patients with all hearing loss types. The majority of implanted patients used the implant at the end of the observation period. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:477-481, 2019.